Expedited Device Registration in Mexico: The Equivalent Pathway
The medical devices market in Mexico is growing significantly and is expected to reach USD 7.6 billion by 2025. It is considered a tough market in terms of medical device regulations. The Federal Commission regulates medical devices in Mexico for the Protection against Sanitary Risk, i.e., COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios). There are different Regulatory pathways for the registration of medical devices in Mexico. Manufacturers may opt for Standard Review or Equivalency Review and may or may not opt for the third-party Reviewer.